Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy

Bukwang Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Diabetic Neuropathies

Treatments

Drug: BK-C-0701

Study type

Interventional

Funder types

Industry

Identifiers

NCT01261143

BK-C-0701-301

Details and patient eligibility

About

The purpose of this study is to determine the:

Primary end point

change of Total symptom score

Secondary end point

neurological test

Full description

total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.

Enrollment

164 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year and is well-controlled.
Patient with symmetric sensory-motor Diabetic Neuropathy which is above stage 2
Result of pin-prick test is 'absent' or 'reduced'
HbA1C <10%
Total Symptom Score ≥ 4 points
At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months.
Patient over 19 years of age
Female who is postmenopausal or is willing to use an effective method of contraception during the study (Effective method=IUD, spermicide with condom, abstinence) or is surgically sterile (underwent a total hysterectomy or bilateral tubal ligation).

Exclusion criteria

Patient who has Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias)
Patient who has Neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as Parkinson's disease/ epilepsy/ Multiple sclerosis, etcs.
Patient who has nerve system disease which can cause sensory loss Myopathy of any cause.
Peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia.
Patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness.
Patients with any active neoplastic disease except benign tumor or nonrecurrent malignant tumor for 5 years.
Patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease that may confound interpretation of the study results or prevent the patient from completing the study.
Patients with atrial fibrillation.
Patients who have had organ transplants of any kind.
Patients with significant hepatic or renal disease (AST, ALT or GGT >2 times normal, serum creatinine >1.8 mg/dL (>159 mmol/l) for males or >1.6 mg/dL (>141 mmol/l) for females).
Patients with a recent history (within last 12 months) of drug or alcohol abuse.
Use of any investigational drug (participation in a clinical trial) within last 1 month.
History of severe or anaphylactic reaction to drugs, sulfur or biologic products.
Recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission.
Existing foot ulcers.
Pregnant or lactating females
History of allergic reaction to the study medication or its excipients.
Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial.
Patient who is not suitable to trial by investigator judgment.
Patient who does not write informed consent prior to start of trial and cannot comply with the trial requirements.
Antioxidant therapy (vitamins E > 400 IU, C > 200 mg, and beta-Carotene > 30 mg) or pentoxyphylline within last 1 month before start of trial.
Use of thioctic acid (> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months.
Use of analgesic within >5times of a half-life before administration of investigational medication.
Use of anticonvulsants(include Pregabalin), antidepressants within 4 weeks before administration of investigational medication.